USA: In a new study conducted by Nicholas G. Nickols and team, it was seen that degarelix did not improve the severity of COVID-19 in males hospitalized with COVID-19 when compared to placebo and standard treatment. The findings of this study were published in the Journal of American Medical Association.
The TMPRSS2 cell surface protease is required for SARS-CoV-2 entrance. Antiandrogen therapy lowers TMPRSS2 expression. The goal of this trial was to see if transient androgen suppression caused by degarelix improved clinical outcomes in COVID-19 inpatients.
The phase 2 HITCH randomized clinical trial compared the effectiveness of degarelix plus standard care vs placebo plus usual care on clinical outcomes in men requiring hospitalization with COVID-19 but not needing invasive mechanical ventilation. From July 22, 2020, through April 8, 2021, inpatients were registered at 14 Department of Veterans Affairs facilities. From August 9 to October 15, 2021, data was evaluated.
Patients were randomly assigned to degarelix (1-time subcutaneous dosage of 240 mg) or a saline placebo based on their age, history of hypertension, and illness severity. Supplemental oxygen, vasopressor support, antibiotics, peritoneal dialysis or hemodialysis, remdesivir, convalescent plasma, intravenous fluids, and dexamethasone were all part of standard therapy. At day 15 following randomization, the composite primary end outcome was death, continued hospitalization, or the need for mechanical ventilation.
The key findings of this study were as follow:
1. The experiment was terminated for futility following the scheduled interim analysis, at which point there were 96 evaluable patients, comprising 62 patients assigned to degarelix and 34 patients randomized to placebo, out of the 198 originally intended. The median age was 70.5 years.
2. Prior to COVID-19, the most common comorbidities were hypertension, chronic obstructive pulmonary disease, asthma, cardiovascular illness, diabetes, and chronic respiratory failure needing supplemental oxygen.
3. There was no significant difference between the degarelix and placebo groups in terms of the primary end point.
4. In addition, there were no differences between the degarelix and placebo groups in any secondary end goals, such as inpatient mortality or all-cause mortality.
5. There were no variations in overall incidence of adverse events, major adverse events, or unanticipated safety concerns between the degarelix and placebo groups.
In conclusion, the HITCH randomized clinical study found that temporary medical castration did not enhance the clinical outcome of COVID-19-infected males in the hospital. In this particular therapeutic context, more research into androgen suppression is not necessary.
Reference:
Nickols NG, Mi Z, DeMatt E, et al. Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial. JAMA Netw Open. 2022;5(4):e227852. doi:10.1001/jamanetworkopen.2022.7852